The purpose of this study is to find out more about the effectiveness of Tadalafil in improving hemodynamic capabilities, endothelial function, and end-organ function in patients who have previously undergone a Fontan Palliation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Mayo Clinic
Rochester, Minnesota, United States
RECRUITINGMicrovascular endothelial function
Measured by the reactive hyperemic index using peripheral artery tonometry (EndoPAT)
Time frame: 52 weeks
Pulmonary vascular reserve
The slope of mean pulmonary artery pressure / cardiac output (mPAP/CO)
Time frame: 52 weeks
Liver stiffness
Liver magnetic resonance elastography (MRE) will be used to assess liver stiffness expressed in Pascals (Pa)
Time frame: 52 weeks
Renal function
Measured by the glomerular filtration rate
Time frame: 52 weeks
Exercise capacity
Assessed using peak VO2 (oxygen consumption) obtained from an upright treadmill or supine bike cardiopulmonary exercise test with echocardiogram
Time frame: 52 weeks
Patient reported quality of life
Measured by the Minnesota Living with Heart Failure Questionnaire that asks subjects to rate how much their heart failure (heart condition) has affected their life during the past month (4 weeks) on a scale of 0=no and 5=very much.
Time frame: 52 weeks
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